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NCT04619407 Clinical Trial

Screening for COVID-19 in Teachers, Childcare Educators, Pupils and Preschoolers

SARS-CoV-2 Clinical Trial

— COKITS  

Official title:
Screening for SARS-CoV-2-Infections in Teachers, Childcare Educators, Pupils and Preschoolers in the State of Mecklenburg-Vorpommern

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04619407
Other study ID # BB 179/20
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 4, 2020
Est. completion date March 26, 2021

Study information
Verified date April 2021
Source University Medicine Greifswald
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main objectives of this study are 1. to establish the prevalence of SARS-CoV-2 in schools and kindergartens in the State of Mecklenburg-Vorpommern in autumn and winter 2020/2021 2. to monitor the future spread of the disease by assessing serological responses to SARS-CoV-2 in teachers and childcare educators over time

Description:

Detailed Description: This study aims to collect information on teachers and childcare educators as well as on pupils and preschoolers in the State of Mecklenburg-Vorpommern Over a 5 month period, 5 study visits per participant are planned. At each visit, nasal/throat swabs (for PCR testing) will be collected and participants will be asked to fill in a questionnaire (asking for SARS-CoV-2 risk factors, perceived risk, and impact of the pandemic on their quality of life). In adults, additional blood samples (for SARS-CoV-2 antibody testing) will be collected at the first and the last study visit. This will help to gain a better understanding of viral load and antibody development over time. The remaining blood samples will be stored in a repository for future research. The study is part of a modular SARS-CoV-2-research programme of the University Medicine Greifswald.

Recruitment information / eligibility
Status Completed
Enrollment 142
Est. completion date March 26, 2021
Est. primary completion date March 26, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 67 Years
Eligibility Inclusion criteria: - See cohort descriptions - Willing to have blood samples stored for future research Exclusion criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Nasopharyngeal swab
SARS-CoV-2 PCR
• Serum testing
Anti-SARS-CoV-2 antibody testing (IgA and IgG ELISA)

Locations
Country Name City State
Germany Greifswald University Medicine Greifswald

Sponsors (4)
Lead Sponsor Collaborator
University Medicine Greifswald Ministry of Education, Science and Culture of the State of Mecklenburg-Vorpommern, Ministry of Social Affairs, Integration and Equality of the State of Mecklenburg-Vorpommern, State Office for Health and Social Affairs of the State of Mecklenburg-Vorpommern

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Share of participants with SARS-CoV-2 detectable in PCR Percentage of SARS-CoV-2 PCR positive participants (children and educational staff) 5 months
Secondary Seroprevalence of SARS-CoV-2 antibodies Percentage of Anti-SARS-COV2 S protein IgA and IgA ELISA positive participants (educational staff) At study inclusion
Secondary Seroprevalence of SARS-CoV-2 antibodies Percentage of Anti-SARS-COV2 S protein IgA and IgA ELISA positive participants (educational staff) 5 months
Secondary SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life As assessed by a monthly questionnaire At study inclusion
Secondary SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life As assessed by a monthly questionnaire 1 month
Secondary SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life As assessed by a monthly questionnaire 2 months
Secondary SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life As assessed by a monthly questionnaire 3 months
Secondary SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life As assessed by a monthly questionnaire 4 months
Secondary SARS-CoV-2 risk factors, perceived risk of infection, and impact of the pandemic on quality of life As assessed by a monthly questionnaire 5 months
Secondary Share of participants with SARS-CoV-2 detectable in PCR Percentage of SARS-CoV-2 PCR positive participants (children and educational staff) At study inclusion
Secondary Share of participants with SARS-CoV-2 detectable in PCR Percentage of SARS-CoV-2 PCR positive participants (children and educational staff) 1 month
Secondary Share of participants with SARS-CoV-2 detectable in PCR Percentage of SARS-CoV-2 PCR positive participants (children and educational staff) 2 months
Secondary Share of participants with SARS-CoV-2 detectable in PCR Percentage of SARS-CoV-2 PCR positive participants (children and educational staff) 3 months
Secondary Share of participants with SARS-CoV-2 detectable in PCR Percentage of SARS-CoV-2 PCR positive participants (children and educational staff) 4 months
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